In Vivo Confocal Microscopy Tumor Atlas Study
Primary Purpose
Brain Neoplasms
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Endomicroscope
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Neoplasms
Eligibility Criteria
Inclusion Criteria:
- All patients with neurological pathology requiring surgery in which tumour resection might be evaluated by using biopsy
Exclusion Criteria:
- History of allergy to fluorescein
- Patients on beta-blockers or ACE inhibitors
- Pregnant women
- Inability to give informed consent
Sites / Locations
- Barrow Neurological Institute, St. Joseph's Hospital and Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All patients
Arm Description
Outcomes
Primary Outcome Measures
Generation of an atlas documenting the comparative features of in vivo microscopy versus traditional histopathology of site-matched biopsies across a range of tumor types and grades.
Secondary Outcome Measures
Test the ability of an expert neuropathologist to predict the outcome of biopsies based on the confocal images collected in vivo.
Capture usability and workflow aspects for the confocal device.
Full Information
NCT ID
NCT01012154
First Posted
November 10, 2009
Last Updated
November 10, 2009
Sponsor
Carl Zeiss Surgical GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01012154
Brief Title
In Vivo Confocal Microscopy Tumor Atlas Study
Official Title
In Vivo Confocal Microscopy Tumor Atlas Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Carl Zeiss Surgical GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to create an atlas based on the preliminary experience of the first feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables documentation of neurological pathology across a range of tumor ypes and grades, suitable for comparison with traditional histopathology from site-matched biopsies.
Detailed Description
Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. The procedure involves a small endoscope which is placed gently into contact with the tissue, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. It is already in clinical use in the field of gastroenterological endoscopy, and investigational use in laparoscopy, dermatology and gynecology. Further, in recent pilot studies endomicroscopy has also been shown to be feasible in bronchoscopy, robot assisted prostatectomy and neurosurgery.The study will use both endomicroscopy and biopsy to document the histological appearance of a range of neurological tumour types and grades.
In subsequent analysis, the confocal image data and corresponding histology data and images will be used to document reliably observable features in the confocal images that are relevant to histopathology interpretation. Relevant images will be selected and discussed by comparison to frozen or permanent section histology for compilation into an atlas documenting comparison for the tumors seen in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Endomicroscope
Intervention Description
Endomicroscopic images and biopsies are taken at several positions on the tumor.
Primary Outcome Measure Information:
Title
Generation of an atlas documenting the comparative features of in vivo microscopy versus traditional histopathology of site-matched biopsies across a range of tumor types and grades.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Test the ability of an expert neuropathologist to predict the outcome of biopsies based on the confocal images collected in vivo.
Time Frame
One week
Title
Capture usability and workflow aspects for the confocal device.
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with neurological pathology requiring surgery in which tumour resection might be evaluated by using biopsy
Exclusion Criteria:
History of allergy to fluorescein
Patients on beta-blockers or ACE inhibitors
Pregnant women
Inability to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Nakaji, MD
Phone
602-406-4808
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Nakaji, MD
Organizational Affiliation
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Nakaji, MD
First Name & Middle Initial & Last Name & Degree
Robert F Spetzler, MD
First Name & Middle Initial & Last Name & Degree
Kris Smith, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Eschbacher, MD
12. IPD Sharing Statement
Learn more about this trial
In Vivo Confocal Microscopy Tumor Atlas Study
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